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临床试验/EUCTR2013-000653-42-BE
EUCTR2013-000653-42-BE进行中(未招募)不适用

Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from colorectal cancer

Jules Bordet Institute0 个研究点开始时间: 2013年2月27日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • - Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for open” surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in first intent”.
  • - Informed consent form signed.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Age less than18 years old.
  • - Inability to give informed consent.
  • - History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  • - Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or dissemi-nated autonomy of the thyroid gland.
  • - Documented coronary disease.
  • - Advanced renal impairment (creatinine > 1,5mg/dl).
  • - During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  • - Pregnancy, breastfeeding

研究者

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